A Study to Understand How the Study Medicine (PF-06823859) Works in People With Active Idiopathic Inflammatory Myopathies [Dermatomyositis (DM) and Polymyositis (PM)]

Last updated: April 9, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Idiopathic Inflammatory Myopathies

Connective Tissue Diseases

Myositis

Treatment

PF-06823859

Placebo

Clinical Study ID

NCT05895786
C0251006
2022-502739-20-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to understand how the study medicine PF-06823859 works in people with idiopathic inflammatory myopathies (DM and PM). These disorders cause inflammation that weakens the muscles that are important for movement and may also cause skin rash in people with DM.

This study is seeking participants who:

  • Are 18 years of age or older or minimum legal adult age as defined per local regulation, whichever is greater

  • Have active DM or active PM.

  • Are receiving a stable dose of 1 corticosteroid taken by mouth and/or 1 traditional immunosuppressant.

    • Note: Corticosteroids and immunosuppressants are medicines that help reduce inflammation and may signal to the immune system not to attack the body.

Dermatomyositis (DM) is a rare disease that causes muscle inflammation that results in muscle weakness and low muscle stamina. Patients with DM have a characteristic skin rash. Polymyositis (PM) is a rare disease that involves mainly muscle inflammation resulting in muscle weakness, that can sometimes be painful. Patients with DM and PM may have trouble going up the steps, walking or getting to a standing position.

Some of the participants will receive the study medicine (PF-06823859) and some will receive placebo (which is similar to study medicine but contains no medicine in it).

The study medicine or placebo will be given as an intravenous (IV) infusion (directly into the veins), which takes about1 hour; every 4 weeks from Day 1 to Week 48 of the study. Both PF-06823859 and placebo and will be given at the study site.

The study will compare the experiences of people receiving study medication to those of the people who do not. This will help to see if PF-06823859 is safe and effective.

Participants will take part in this study for about 13 months. During this time, participants will have 15 study visits. These visits will be performed at the study site.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female adults (≥18 years old or minimum legal adult age as defined per localregulation, whichever is greater)

  • Active dermatomyositis (DM) or polymyositis (PM) with age of onset

  • 18 years old.

  • Must be receiving a stable dose of standard of care (SOC) background medications atthe time of enrollment.

Exclusion

Exclusion Criteria:

  • Myositis due to non-Idiopathic inflammatory myopathies (non-IIM)

  • Existing diagnosis of inclusion body myositis (IBM)

  • Presence of immune-mediated necrotizing myositis (IMNM)

  • Myositis with end-stage organ involvement

  • Active bacterial, viral or fungal infections or hospitalizations for seriousinfections within 60 days prior to enrollment

  • History of recurrent bacterial, viral, fungal, mycobacterial or other infections

  • Clinically significant finding on a chest x-ray

  • Have cancer or a history of cancer within 5 years of screening

  • Significant current or prior disease conditions that may interfere with the responseto or safety of the study medicine, including but not limited to:

  • history of major organ transplant

  • acute coronary syndrome or any history of significant cerebrovascular disease within 24 weeks of screening

  • preexisting demyelinating disorder such as multiple sclerosis, or other severeneurological disorder

  • major surgery within 4 weeks of screening, or scheduled to occur during the study,excluding diagnostic surgery

  • previous treatment with total lymphoid irradiation

  • history of any lymphoproliferative disorder such as Epstein Barr Virus, history oflymphoma, leukemia, or symptoms of current lymphatic or lymphoid disease

  • Clinically significant depression, suicidal ideation, or previous history ofsuicidal behaviors

  • Other medical or laboratory abnormality that may increase the risk of studyparticipation

  • Previous administration with an investigational product (drug or vaccine) within 30days or of the first dose of study medicine

  • Current use or incomplete appropriate washout period of any prohibited medication(s)or known exposure to anti-interferon beta (PF-06823859) or any type ofanti-interferon beta therapy

  • Prior SOC medication that does not fulfill the criteria

  • Certain laboratory results from screening assessments that may interfere with studyparticipation.

  • Investigator site staff directly involved in the conduct of the study and theirfamily members, site staff and sponsor and sponsor delegate employees directlyinvolved in the conduct of the study and their family members

Study Design

Total Participants: 270
Treatment Group(s): 2
Primary Treatment: PF-06823859
Phase: 3
Study Start date:
May 20, 2023
Estimated Completion Date:
July 28, 2026

Connect with a study center

  • Instituto de Investigaciones Clinicas Zarate

    Zárate, Buenos Aires B2800DGH
    Argentina

    Site Not Available

  • CER medical Institute

    Quilmes, Ciudad Autónoma DE Buenos Aires B1878
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Médicas Tucuman

    SAN M. DE Tucuman, Tucumán T4000AXL
    Argentina

    Active - Recruiting

  • Hospital J. M. Ramos Mejía

    Ciudad Autónoma de Buenos Aires, C1221ADC
    Argentina

    Site Not Available

  • Instituto de Reumatología

    Mendoza, 5500
    Argentina

    Site Not Available

  • UZ Leuven

    Leuven, Vlaams-brabant 3000
    Belgium

    Site Not Available

  • Hopital Erasme

    Brussels, 1070
    Belgium

    Site Not Available

  • Medical Center Artmed

    Plovdiv, 4000
    Bulgaria

    Active - Recruiting

  • Diagnostic Consultative Centre (DCC) - Foкus 5

    Sofia, 1612
    Bulgaria

    Site Not Available

  • Anhui Provincial Hospital

    Hefei, Anhui 230001
    China

    Active - Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Cangzhou People's Hospital

    Cangzhou, Hebei 061011
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Shanghai Jiaotong University School of Medicine, Renji Hospital

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Cheng Du, Sichuan 610041
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan Sheng 650032
    China

    Active - Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche

    Reims, 51092
    France

    Site Not Available

  • Hopitaux Universitaires de Strasbourg, Nouvel Hopital Civil

    Strasbourg, 67091
    France

    Active - Recruiting

  • Universitaetsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Ludwig Maximilians University Munich Klinikum

    Munchen, 80336
    Germany

    Site Not Available

  • Budai Irgalmasrendi Korhaz

    Budapest, 1027
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Active - Recruiting

  • Institute of Neurosciences

    Surat, Gujarat 395001
    India

    Active - Recruiting

  • Medanta-The Medicity

    Gurugram (Gurgaon), Haryana 122001
    India

    Site Not Available

  • CHARM HEALTHCARE PRIVATE LIMITED (Previously Dr Shenoy's Care Private Limited)

    Cochin, Kerala 682040
    India

    Active - Recruiting

  • Dr. Shenoy's Care

    Cochin, Kerala 682040
    India

    Active - Recruiting

  • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

    Kolkata, WEST Bengal 700020
    India

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, Hamerkaz 4941492
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Ramat Gan, Hamerkaz 5265601
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv, Tell Abīb 6423906
    Israel

    Active - Recruiting

  • Fondazione Policlinico Tor Vergata

    Rome, Lazio 00133
    Italy

    Active - Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM 00168
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Policlinico G.Rodolico-San Marco Di Catania

    Catania, 95121
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Firenze, 50139
    Italy

    Active - Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Site Not Available

  • Irccs Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • Hospital of the university of occupational and environmental health

    Kitakyushu-shi, Fukuoka 807-8556
    Japan

    Active - Recruiting

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, Hokkaido 0700901
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • St. Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa 216-8511
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai-shi, Miyagi 980-8574
    Japan

    Site Not Available

  • Okayama City General Medical Center Okayama City Hospital

    Okayama-shi, Okayama 700-8557
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka Minami Medical Center

    Kawachinagano, Osaka 586-8521
    Japan

    Active - Recruiting

  • Shiga University of Medical Science Hospital

    Otsu, Shiga 520-2192
    Japan

    Active - Recruiting

  • Institute of Science Tokyo Hospital

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo 113-8603
    Japan

    Active - Recruiting

  • Tokyo Medical And Dental University Hospital

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700-8557
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Tokyo, 160-0023
    Japan

    Site Not Available

  • Chonnam National University Bitgoeul Hospital

    Gwangju, Kwangju-kwangyokshi 61748
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 02447
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Distrito Federal 06100
    Mexico

    Active - Recruiting

  • Cryptex Investigación Clínica S.A. de C.V.

    Cuauhtémoc, Ciudad De México, Distrito Federal 06100
    Mexico

    Site Not Available

  • CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas

    Mexico City, Distrito Federal 06700
    Mexico

    Site Not Available

  • Centro Integral en Reumatologia

    Guadalajara, Jalisco 44160
    Mexico

    Site Not Available

  • Consultorio Privado Dr. Miguel Cortes Hernández

    Cuernavaca, Morelos C.P. 62290
    Mexico

    Site Not Available

  • Private Practice - Dr. Miguel Cortes

    Cuernavaca, Morelos 62448
    Mexico

    Active - Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

    Warsaw, Mazowieckie 02-637
    Poland

    Active - Recruiting

  • Centrum Medyczne Plejady

    Krakow, Małopolskie 30-363
    Poland

    Active - Recruiting

  • 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

    Kraków, Małopolskie 30-901
    Poland

    Active - Recruiting

  • Lux Med

    Kraków, Małopolskie 30-415
    Poland

    Active - Recruiting

  • Małopolskie Centrum Kliniczne

    Kraków, Małopolskie 30-149
    Poland

    Active - Recruiting

  • Pracownia Radiologiczna WIDOK-MED

    Kraków, Małopolskie 30-147
    Poland

    Active - Recruiting

  • Centrum Medycyny Oddechowej Robert Mroz spolka jawna

    Bialystok, Podlaskie 15-044 Bialystok
    Poland

    Active - Recruiting

  • Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty

    Bialystok, Podlaskie 15-707
    Poland

    Active - Recruiting

  • Nova Reuma Społka Partnerska

    Bialystok, Podlaskie 15-707
    Poland

    Active - Recruiting

  • INTER CLINIC Piotr Adrian Klimiuk

    Białystok, Podlaskie 15-077
    Poland

    Active - Recruiting

  • Zaklad Diagnostyki Obrazowej HEM s.c.

    Białystok, Podlaskie 15-369
    Poland

    Active - Recruiting

  • Narodny ustav reumatickych chorob

    Piešťany, 921 12
    Slovakia

    Active - Recruiting

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [LA Coruña] 15006
    Spain

    Site Not Available

  • Hospital Universitario QuironSalud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    La Laguna, Santa CRUZ DE Tenerife 38320
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Karolinska University Hospital Solna

    Stockholm, 17164
    Sweden

    Site Not Available

  • Chi Mei Medical Center

    Tainan City, Tainan 71004
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 404332
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Ankara University Ibni Sina Hospital

    Ankara, 06230
    Turkey

    Site Not Available

  • Hacettepe Universite Hastaneleri

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Memorial Ankara Hastanesi

    Ankara, 06520
    Turkey

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, Glasgow CITY G51 4TF
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford, Manchester M6 8HD
    United Kingdom

    Site Not Available

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • AARA Clinical Research - Arizona Arthritis & Rheumatology Associates- Glendale

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Associates, P.C.

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Arizona Arthritis & Rheumatology Research, PLLC

    Glendale, Arizona 85306
    United States

    Active - Recruiting

  • Mayo Clinic Hospital

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona 85259
    United States

    Active - Recruiting

  • 200 UCLA Medical Plaza

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UCLA Clinical & Translational Research Center (CTRC)

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Center for Clinical Research - Chapman Pavilion

    Orange, California 92868
    United States

    Site Not Available

  • UCI Douglas Hospital

    Orange, California 92868
    United States

    Site Not Available

  • UCI Health Center for Innovative Health Therapies

    Orange, California 92868
    United States

    Site Not Available

  • University of California - Irvine

    Orange, California 92868
    United States

    Site Not Available

  • Inland Rheumatology & Osteoporosis Medical Group

    Upland, California 91786
    United States

    Site Not Available

  • University of Miami

    Coral Gables, Florida 33136
    United States

    Active - Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Lal Bhagchandani, M.D

    Margate, Florida 33063
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33125
    United States

    Active - Recruiting

  • University of Miami Dermatology Clinical Trials Unit

    Miami, Florida 33125
    United States

    Active - Recruiting

  • Omega Research Orlando

    Orlando, Florida 32808
    United States

    Site Not Available

  • IRIS Research and Development, LLC

    Plantation, Florida 33324
    United States

    Site Not Available

  • West Broward Pulmonary Consultants

    Plantation, Florida 33324
    United States

    Site Not Available

  • West Broward Rheumatology Associates

    Tamarac, Florida 33321
    United States

    Site Not Available

  • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU)

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • KU Clinical Research Center - Clinical and Translational Science Unit (CTSU) Rainbow

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kansas Medical Center - Hoglund Brain Imaging Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • CTH - Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Washington University Pulmonary Function Laboratory

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Joseph S. and Diane H. Steinberg Ambulatory Care Center

    Brooklyn, New York 11201
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Health - Clinical and Translational Science Institute Research Pharmacy

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Health Clinical Research Center

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Rad1ology

    New York, New York 10016
    United States

    Active - Recruiting

  • NYU Langone Radiology

    New York, New York 10016
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Arthritis & Rheumatology Research Institute

    Allen, Texas 75013
    United States

    Active - Recruiting

  • Arthritis and Rheumatology Research Institute

    Allen, Texas 75013
    United States

    Active - Recruiting

  • Integrative Rheumatology of South Texas

    Edinburg, Texas 78539
    United States

    Active - Recruiting

  • Integrative Rheumatology of South Texas - Harlingen

    Harlingen, Texas 78550
    United States

    Active - Recruiting

  • DLCO

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Nerve & Muscle Center of Texas

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Pulmonary and Sleep Center of the Valley

    Weslaco, Texas 78596
    United States

    Active - Recruiting

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Active - Recruiting

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